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Featured Stories


Relentless Rise Of Transcatheter Tech: Heart Valve Repair Turns Back On Open Surgery

The global market for products treating heart valve disease is expected to exceed $8bn by 2021, driven largely by the rising number of elderly patients with cardiovascular disease, obesity and growing prevalence of diabetes. This, in turn, is fueling significant innovation in minimally invasive techniques, particularly in the leading area of transcatheter aortic valve replacement (TAVR), but also in transcatheter mitral valve repair (TMVrep) systems, both of which offer patients quicker recovery times, less discomfort and greater safety compared to traditional surgical heart valve repair and replacement. This feature looks more closely at the competitive landscape and dynamics of these two fast-growing market segments, as well as gives insight into what the users – the physicians – think of these technologies.

Cardiovascular Surgical Procedures Market Intelligence

Medicare Agency Solicits Input On ICD Coverage For First Time Since 2005

The US Medicare agency opened a national coverage analysis to reconsider coverage indications for implantable cardioverter defibrillators and received input from 35 individuals, organizations, and companies during the initial public comment period. The agency did not specify any particular issues or deficiencies that it wants to address by updating its coverage policy, but CMS has not reconsidered the national coverage policy on ICDs since a major coverage expansion was implemented in 2005.

Medicare Market Access Clinical Trials

Insulet, Ypsomed Split Up And Go Head-To-Head In Insulin Pump Market

Insulin pump commercial partners Insulet and Ypsomed will be parting ways after some eight years in an exclusive distribution alliance. The companies failed to reach an agreement to renew the distributor agreement, which will end June 2018, following differences on price. Ypsomed announced it will introduce its own tubeless insulin pump in the mid-term.

Diabetic Care Companies Commercial

Device Week – July 21, 2017

On this week's Medtech Insight podcast: US Senate passes $2.8bn FDA spending bill; US approvals and clearances strong in first six months of 2017; the global heart-valve repair and replacement devices market is highlighted.

Medical Device FDA Approvals
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Policy & Regulation Explore this Topic

Set Alert for Policy

Unlocking Legalities: Ninth Circuit Allows Wider Range Of False Claim Suits

The Ninth Circuit Court of Appeals allowed False Claims Act allegations against drug manufacturers Gilead Sciences to move forward despite a US Supreme Court ruling last year that raised FCA standards.

Medical Device Legal Issues Unlocking Legalities

How Does UL Acquisition Of Emergo Consultancy Answer Conflict Of Interest Issues?

The recent acquisition of the Emergo medtech consultancy by Underwriters Laboratory has raised a few eyebrows in the sector. Can a notified body and consultancy co-exist without conflicts of interest?

Europe Medical Device Regulation

Class I Recall On Penumbra Revascularization Device

A delivery wire in the stroke treatment device can break or separate during use, putting patients at risk of worsened stroke, death and other adverse events.

Recalls Neurology

India Consults On ‘Essential Principles’ Ahead Of New Rules For Devices, IVDs

India’s draft guidance describes fundamental design and manufacturing requirements that, when met, indicate a medical device or IVD is safe and performs to its specification.

India Asia Pacific

Lacking A New Budget Cap, Senate Panel Passes $2.8Bn Funding Bill For FDA

The Senate Appropriations Committee, forced to adhere to 2017 spending rules due to an impasse between the president and Congress, approved an Agriculture/FDA spending bill that would give FDA $2.8bn in discretionary dollars for 2018.

Policy Legislation

Brexit Health Alliance Adds To UK-EU Debate; Medtechs Settle Into Interim Brexit Pace

The pace of Brexit-related work that impacts the UK medtech industry shows no sign of slowing over the summer. In view of unexpected – uncomfortable for some – recent opinion poll findings, there is unlikely to be a significant change in somewhat febrile UK atmosphere anytime soon. And the future UK medtech regulatory situation still needs close attention.

United Kingdom EU

You Say Goodbye, I Say Hello – MHRA Moves In, EMA Moves Out

The UK Medicines and Healthcare products Regulatory Agency is relocating to the very area in east London the European Medicines Agency is being forced to abandon.

Europe United Kingdom

Disposable DME Could Save On Medicare Costs, Says GAO Report

Disposable medical equipment could save the Medicare program three-to-four times its current costs for certain categories of durable medical equipment. But the agency would have to make major changes to its current definitions, with Congress' help, to provide some options for coverage of the disposable alternatives, the US Government Accountability Office found.

Reimbursement Policy

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Latest From Quality Control

US FDA Maturity Model Pilot Program Gets October Meeting Date

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

Quality Control Compliance

Compliance Corner: 6 Tips From US FDA To Ensure Robust Software Validation

Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.

Quality Control Compliance

Aerospace Heat Treating Standard Recognized By US FDA, Giving Nudge To MedAccred Supplier-Control Program

The agency's Center for Devices and Radiological Health has formally recognized pyrometry standard AMS 2750 for heat treating. Originally drafted by SAE International in 1980 for the aerospace industry, the standard is the foundation of heat treating audit criteria for the burgeoning medical device supply-chain oversight program MedAccred.

Quality Control Medical Device

Commercial Explore this Topic

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numares Targets 2018 For Metabolomic Bladder Cancer Test

German diagnostics firm numares AG is targeting 2018 for a launch of a bladder cancer test based on its metabolomic biomarker network technology. The company obtained promising results from a retrospective study indicating that evaluation of metabolomic biomarker networks can be used as a diagnostic for bladder cancer.

In Vitro Diagnostics Cancer Companies

Latest From Commercial

Alere Off-Loads Blood Gas Business To Siemens

Alere is selling its Epocal point-of-care blood diagnostics subsidiary to Siemens Healthineers to comply with US antitrust requirements in advance of its pending acquisition by Abbott. Siemens plans to integrate Epocal's epoc blood analysis system with its digital platforms and its existing point-of-care diagnostics.

Commercial Deals

'Profitable, High-Growth' CellRight Bulks Up Tissue Regenix's Ortho Biz

In acquiring CellRight Technologies, a young but already profitable US company specializing in regenerative bone technologies, UK regenerative medicine firm Tissue Regenix will significantly bulk up its portfolio and accelerate its global commercial growth plans.

M & A Regenerative Medicine

Alere Unloads Its Triage Assets To Quidel

The deal, subject to the completion of Abbott's planned acquisition of Alere, includes the Triage MeterPro cardiovascular and toxicology businesses, as well as the Triage BNP business. These additions will diversify Quidel's portfolio of rapid diagnostic products for critical care settings and give it a stronger presence in the point-of-care market.

In Vitro Diagnostics M & A

Judge Rules For Enhanced Damages In Zimmer-Stryker Patent Spat

The case had gone to the US Supreme Court due to a dispute over the standards for enhanced damages. Zimmer, which was ordered to pay almost $250m in costs and penalties, expects to appeal the verdict.

Legal Issues Intellectual Property

Medtronic Computer Crash To Have Limited Impact

Despite a major a computer crash, Medtronic is confident it will meet its revenue growth projections for the first quarter. The company also says there is currently no indication the crash was the result of an outside agent such as the recent WannaCry and Petya worms.

Manufacturing Sales & Earnings

Philips Persists With M&A Strategy; Snaps Up Ultrasound Dx Biz

Philips is strengthening its hand in cardiac ultrasound with the addition of German ultrasound firm TomTec Imaging Systems, its seventh acquisition of the year. Financial terms of the deal were not disclosed.

Diagnostic Imaging M & A

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

OUS Approvals: Neurostim And Cardiovascular Lead June Surge

Approvals of neurostimulation and cardiology devices dominated the list of non-US medtech approvals in June. According to Medtech Insight's Approvals Tracker, there were 36 medtech approvals outside the US last total that month, including 28 CE marks in Europe, plus approvals from China, Canada, Australia/New Zealand and Brazil.

Approvals Innovation Research & Development

Latest From Research & Development

Humabs Biomed Zika Assay Pinpoints Virus From Other Flavivirus Infections

A novel antibody-based Zika virus assay developed by Humabs Biomed, the NS1 Blockade-of-Binding (BOB) ELISA, can accurately distinguish Zika virus from other viruses, and differentiate it from other flavivirus infections within three hours, according to a recent article in the Proceedings of the National Academy of Sciences. Work to commercially develop the test is just beginning, so the company has not yet submitted it to FDA.

In Vitro Diagnostics United States

Agendia Touts ASCO Guideline's Endorsement Of MammaPrint Breast Cancer Test

Results of the MINDACT trial, which show that Agendia BV's MammaPrint 70-gene lab test can identify about half of the early-stage breast cancer patients who do not need chemotherapy, has led the American Society of Clinical Oncology to specifically recommend the test in its guidelines.

Clinical Trials Market Access

Digital Update: UK Peer Pressure, US Tech Advances And EU Common Goals Put eHealth To Top Of Agenda

Funding is taking a long time to come through for the UK NHS's digital health care transformation, but as the national provider's head of technology strategy, Dr Paul Rice says, "We can't afford to remain non-digital." Estonia, currently holding the presidency of the EU Council of Ministers, gets that too, while US digital champions like Kaiser Permanente and disruptive technology inventors like Mindstrong Health are forcing the pace.

Digital Health Medical Device

First MRI Scanner Designed For NICU Babies Gets US Clearance

Israel's Aspect Imaging has scored the first 510(k) for an MRI machine specifically designed to scan infants in neonatal intensive care units where radiowaves from traditional MRIs could risk interfering with other hospital equipment.

Pediatrics Approvals

US Approvals Analysis: FDA Delivers Strong Half-Year Volumes

US FDA Device-approval volumes were strong during the first half of 2017 for all review pathways. Medtronic and Siemens have so far captured the most 510(k) clearances, with Cook close behind. That and more from Medtech Insight's Approvals Tracker.

Approvals Innovation

Myriad Innovations At MedFIT, But Graphene Wound Dressing And Back Pain Relief Exoskeleton Get The Votes

The first edition of the European medtech partnering conference MedFIT provided a showcase for early-stage innovations emerging from the R&D labs of start-ups and tech incubators, all poised to be taken to the next level of clinical evaluation or even commercialization. Medtech Insight attended the event's Start-Up Slam where eight medtech innovations vied to win over the jury of potential investors and industry experts, as well as the audience.

Innovation StartUps and SMEs
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